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MP-3 Biofeedback Training and Central Vision Loss

The Effect of Varied MP-3 Biofeedback Training on Visual Functions in Central Vision Loss: a Randomized Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05772780
Enrollment
24
Registered
2023-03-16
Start date
2021-10-01
Completion date
2022-02-09
Last updated
2023-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-Related Macular Degeneration

Brief summary

The objectives of this investigation are: * evaluate the results of rehabilitation treatment using photostimulation with a structured stimulus in two different samples of low vision subjects with central vision loss who will be subjected to biofeedback at the MP3 microperimeter with different timing; * compare the effectiveness of the rehabilitation treatments in the two groups to provide useful indications for proposing standardisation of the rehabilitation pathway focusing on photostimulation in subjects with central vision loss.

Interventions

DEVICEMP-3 microperimeter

Biofeedback stimulation two days a week

Sponsors

Amore Filippo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Age related macular degeneration

Exclusion criteria

* Cognitive impairment; concomitant eye disease; significant media opacities; ocular surgery within previous 90 days

Design outcomes

Primary

MeasureTime frameDescription
Fixation stability6 monthsAchievement of a stable fixation, defined according to Fuji classification (Stable: if more than 75% of the fixation points are inside a 2° diameter circle that has as a center the centroid of all fixation points) and the Bivariate Contour Ellipse Area, were selected as primary outcomes.
Reading speed6 monthsAchievement of good reading speed: higher than 87 words per minutes was defined as our secondary outcome. Parameters for words per minutes are referred to visually impaired functional reading reported in literature

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026